Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACI SINGLE LUMEN BIOPSY NEEDLE

K-Number: K954264 · 1995-11-29

ApplicantAdvanced Cytometrix, Inc.
Decision Date1995-11-29
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACI SINGLE LUMEN BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cytometrix, Inc.. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K954264. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACI SINGLE LUMEN BIOPSY NEEDLE?

ACI SINGLE LUMEN BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Advanced Cytometrix, Inc.. The 510(k) number is K954264.

When did ACI SINGLE LUMEN BIOPSY NEEDLE receive FDA 510(k) clearance?

ACI SINGLE LUMEN BIOPSY NEEDLE received FDA 510(k) clearance on 1995-11-29, under 510(k) number K954264.

Who is the listed applicant for ACI SINGLE LUMEN BIOPSY NEEDLE?

The FDA 510(k) record lists Advanced Cytometrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACI SINGLE LUMEN BIOPSY NEEDLE?

The FDA product code for ACI SINGLE LUMEN BIOPSY NEEDLE is BTA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Advanced Cytometrix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954286ACI PULSATING VACUUM PUMP SYSTEMK954287ACI FINE NEEDLE ASPIRATION BIOPSY KIT

Related Devices (Code: BTA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑